Database Management Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Database Management flashcards as text
What is the function of a user acceptance testing (UAT) plan in clinical database setup?
Answer: To verify that the database meets user requirements before go-live
UAT verifies that the clinical database functions according to the specified user requirements and is fit for purpose before it is deployed for live data collection.
In clinical data management, what does 'soft coding' of adverse events mean?
Answer: Assigning temporary codes that must be confirmed by a medical coder
Soft coding assigns preliminary or tentative codes to adverse events that are subject to review and confirmation by a qualified medical coder before being finalized.
Which action must be taken before unblinding the database in a double-blind clinical trial?
Answer: Completing all database reconciliation and locking the database
The database must be fully cleaned, reconciled, and locked before unblinding to prevent bias in data cleaning that could occur if treatment assignments were known.
What is the role of a Data Safety Monitoring Board (DSMB) in relation to the clinical trial database?
Answer: To conduct periodic reviews of accumulating data to monitor participant safety
A DSMB periodically reviews accumulating unblinded data to monitor participant safety and trial integrity, potentially recommending early termination if needed.
What does 'database migration' refer to in a clinical trial context?
Answer: Transferring clinical data from one system to another, often with format changes
Database migration involves transferring clinical data from one system or format to another, requiring validation to ensure data integrity is maintained throughout the process.
Which programming language is most commonly used for querying relational clinical trial databases?
Answer: SQL
SQL (Structured Query Language) is the standard language used to query, retrieve, and manipulate data in relational databases used in clinical trials.
What is the purpose of an edit check specification document in clinical database management?
Answer: To document all programmatic validation rules applied to the database
An edit check specification document describes all the validation rules and logical checks that will be programmed into the database to detect data errors or inconsistencies.